MASSDEVICE ON CALL — Medical device industry lobby AdvaMed proposed six policy initiatives, including trade, tax, payment, regulatory and research policies that ask government to make innovation in the life sciences a top priority.
AdvaMed unveiled its "Competitiveness Agenda" during a visit to orthopedic giant Stryker Corp.’s (NYSE:SYK) Kalamazoo, Mich. manufacturing facility.
"We know medical technology has a bright future," said AdvaMed president & CEO Stephen Ubl. "The question is: Will that future be made in America—or somewhere else? Without the right public policies in place to provide a level playing field between the U.S. and foreign competitors, America’s leadership will be lost."
The lobby called for the While House to establish an office of medical innovation, which would be responsible for overseeing existing and proposed government policies that may affect medical innovation, Healthwatch reported.
AdvaMed’s six recommendations were:
- Make innovation in life sciences a priority.
- Reform the FDA review process.
- Establish payment policies that support innovation.
- Encourage trade policies that support growth and provide a level playing field for domestic manufacturing.
- Implement strategic tax policies to level the playing field.
- Sustain and improve American research and development.
"We’re one of the crown jewels of American industry, and we often get overlooked," said Stryker CEO Stephen MacMillan.
FDA defends its scientific process
The U.S. Food & Drug Administration is up in arms over an amendment passed through the House Appropriations Committee seeking to modify FDA funding to only activities based on "hard science."
"This amendment ties FDA’s hands and will prevent the agency from taking basic steps to protect us from highly lethal threats, like tainted foods and drugs," Rep. Henry Waxman (D-Calif.), one of the sponsors of the 2009 law that gave the FDA authority to regulate tobacco, said in a statement. "Simply put, it will endanger American lives."
The amendment, introduced by Rep. Denny Rehberg (R-Mont.), restricts the FDA from taking action unless its motives are supported by "hard science," rather than based on cost or consumer behavior. Rehberg defined "hard science" as "perceived as being more scientific, rigorous and accurate" than behavioral and social sciences, the Washington Post reported.
"I hate to try and define the difference between a psychiatrist and a psychologist, between a sociologist and a geologist, but there is clearly a difference," Rehberg said.
Insurance is just one factor in emergency room traffic, new study says
The number of low-severity visits to Massachusetts emergency departments dropped slightly since the implementation of the state’s health care reform law, according to researchers at Beth Israel Deaconess Medical Center. Overall emergency department visits continue to rise.
"Our study suggests other factors play a role in determining access to care and use of the ED in addition to one’s insurance status," said Dr. Peter Smulowitz, the study’s lead investigator and an emergency physician at BIDMC. "These likely include availability of primary care, convenience of ED hours, the ability to obtain a comprehensive evaluation and testing at one time in the ED."
Sex supplement boost post-chemo qualify of life for cancer survivors
A product available for the last decade as a sexual aid may have the added benefit of helping female cancer survivors alleviate their post-cancer symptoms, according to researchers at Wake Forest University.
ArginMax, developed by the Daily Wellness Company, was originally developed as a natural nutritional supplement to enhance sexual performance for both men and women. While the product doesn’t improve sexual function for female cancer survivors, it did improve symptoms like lack of energy, pain, nausea and sleeplessness.
"They reported a greater enjoyment of life, without any additional side effects from the supplement," said Dr. Kathryn Greven, radiation oncologist at Wake Forest Baptist Medical Center.
Ximedica expands to Minnesota
Ximedica announced the opening of a regional office at the University Enterprise Laboratories Center in Minneapolis. This is the third facility for the company, which is headquartered in Providence, R.I.
The Minnesota office will serve as a central hub for Ximedica’s Midwest client base, according to the release.